BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SUCTION/IRRIGATOR TUBING KIT

    K Number: K952605 · Decision Sep 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    206
    Registration Numbers
    206
    Same Product Code
    26
    Applicant Total
    51
    Review Days
    101

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    Basic Information

    Device Name
    SUCTION/IRRIGATOR TUBING KIT
    K Number
    K952605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Laser Technologies, Inc.
    Date Received
    June 6, 1995
    Decision Date
    September 15, 1995
    Product Code
    GAZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GAZ Tubing, Noninvasive

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    MAXI-FLOW SUCTION SET 12 FT.

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